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Clinical study on treatment of high risk foot of Diabetes by invigorating spleen, removing turbidity and dredging collaterals based on the change of intestinal microflora

Clinical study on treatment of high risk foot of Diabetes by invigorating spleen, removing turbidity and dredging collaterals based on the change of intestinal microflora

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080512
Enrollment
Unknown
Registered
2024-01-31
Start date
2023-03-01
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes foot

Interventions

T1 (Health Education+Cilostazol+TCM prescription):none
T2 (Health Education+Cilostazol+TCM prescription):none
C (Health Education+Cilostazol):none

Sponsors

Subei People’s Hospital of Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for high-risk foot of diabetes,and TCM syndrome of cold coagulation blocking collaterals, phlegm and blood stasis blocking collaterals. 2.No limb ischemic diseases such as Takayasu arteritis, Raynaud's disease or thromboangiitis obliterans. 3.Men and women are not limited. 4.Between 18 and 80 years old. 5.conscious and generally in good condition,cooperate with examination. 6.Volunteer to participate in the research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Type 1 diabetes 2.Acute complications of type 2 diabetes, such as ketosis, hyperglycemia and hyperosmolality in diabetes. 3.Patients with limb ischemic diseases such as Takayasu arteritis, Raynaud's disease or thromboangiitis obliterans. 4.Have serious heart, liver, kidney and other complications or mental diseases. 5.Women who have recently planned to be pregnant or breastfeeding. 6.Wagner of diabetes foot is divided into 1-5 grades. 7.Allergy or intolerance to the test drug.

Design outcomes

Primary

MeasureTime frame
Intestinal microorganisms 16S amplicon sequencing;blood sugar;HbA1c;B-mode ultrasonography;Determination of foot blood oxygen saturation;ABI;

Secondary

MeasureTime frame
Claudication index;Pain;Skin color;Skin temperature;

Countries

CHINA

Contacts

Public ContactLiu Yan

Subei People’s Hospital of Jiangsu Province

cathy1sun@126.com+86 180 5106 1258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026